Manager, Regulatory Submission Management

Requirements

• 6+ Years with BS/BA
• OR
• 4+ Years with MS/MA
• BA/ BS with 6+ relevant

Benefits

Additional Information

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Regulatory Submission Management acts as a partner for strategic planning and execution of the portfolio, to ensure global Regulatory submissions are scalable, seamless, and optimized. We are a trusted companion across Regulatory Affairs, bridging strategy and execution while building knowledge across the portfolio to bring therapies to patients faster, together. You will execute a wide range of regulatory submissions independently, including submissions of high complexity, contribute to global submission content plans, and lead review and planning processes for multiple products or projects. You will represent Regulatory Submission Management (RSM) on relevant product, project, and/or regulatory submissions teams, providing specialist guidance on regulatory submissions requirements and timing. You may also represent RSM on other cross-functional initiatives. You will plan and have oversight for assigned deliverables and may serve as the RSM lead for small to medium regulatory submissions. You will participate in identifying/developing process improvements, new standards, and updating systems in support of submissions. You may coach, train, and provide guidance to less experienced RSM colleagues. Essential Duties and Job Functions: Manages a wide variety of global submissions, such as clinical study reports (CSRs), investigator's brochures, DSURs, regulatory responses, original INDs and amendments. May represent RSM in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal strategies to achieve speed-to-filing or meet technical health authority requirements; may act as a technical and operational lead for submission execution. Plans and oversees assigned submissions with responsibilities including development and management of global and regional content plans and resource planning for assigned submissions. Acts as a Subject Matter Expert for various expertise related to RSM Core Capabilities Supports regulatory maintenance activities for early development and late-stage products. Supports the planning and preparation activities of regulatory deliverables with direction from an RA Liaison and/or GRAD Affiliate May serve as the RSM lead for small to medium regulatory submissions. May serve as lead submission manager and department representative across development programs. Organizes preparation of high-quality documents for internal stakeholders. Author documents and/or procedures for submissions such as cover letters, forms and other documents as assigned. Participates in development/improvement of submission standards, submission templates, and validation decision trees. May also participate in other special projects and/or represent RSM in other cross-functional initiatives. Where applicable, oversees the work of external contractors supporting deliverables and other activities. Act as the primary interface with the publishing team to plan and negotiate publishing timelines and deliverables. May coach, train, and provide guidance to less experienced Submission Management colleagues. Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

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